FDA Box Warning

• Postmarketing reports indicate that the effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects, including asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These signs and symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and deaths have occurred.

• The risk of signs and symptoms is probably greatest in children treated for spasticity, but signs and symptoms can also occur in adults treated for spasticity and other conditions, particularly in patients who have underlying conditions that would predispose them to these symptoms.

• In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at dosages comparable to those used to treat cervical dystonia and at lower dosages.

Action

Blocks neuromuscular transmission by binding to receptor sites on motor nerve terminals and inhibiting acetylcholine release, thereby causing localized muscle denervation. As a result, local muscle paralysis occurs, which leads to muscle atrophy and reinnervation due to development of new acetylcholine receptors.

Indications and dosages

Adults ages 65 and younger:Botox cosmetic only-Total of 20 units (0.5-ml solution) injected I.M. as divided doses of 0.1 ml into each of five sites: two in each corrugator muscle and one in procerus muscle. Injection usually needs to be repeated q 3 to 4 months to maintain effect. Dysport-50 units I.M. in five equal aliquots of 10 units each to achieve clinical effect

Adults: 1.25 to 5 units injected into eyelid (dosage varies with strabismus severity). Dose can be repeated in 7 to 14 days if patient has adequate response; with inadequate response, dosage may be doubled.

➣ To relax skeletal muscles and reduce severity of abnormal head position and neck pain associated with cervical dystonia

Adults:Botox-Usual dosage is 236 units injected I.M. locally into affected muscles. Dosage ranges from 198 to 300 units. Dysport-500 units I.M. as a divided dose among affected muscles in patients with or without a history of prior treatment with botulinum toxin.

• Rotate vial gently to mix drug; then draw up at least 20 units (0.5-ml solution) and expel air bubbles.

• Remove needle used for reconstitution, and attach 30G needle. Then inject drug as divided doses of 0.1 ml into each of five sites (two in each corruga-tor muscle, one in procerus muscle).

• Prepare eye with several drops of local anesthetic and ocular decongestant, as prescribed, several minutes before injection for blepharospasm or strabismus.

• When administering for upper limb spasticity, dilute with preservative-free normal saline solution to 200 units/4 ml or 100 units/2 ml. Then, using a 25G to 30G needle for superficial muscles and a longer 22G needle for deeper musculature, inject no more than 50 units per site.

All content on this website, including dictionary, thesaurus, literature, geography, and other reference data is for informational purposes only. This information should not be considered complete, up to date, and is not intended to be used in place of a visit, consultation, or advice of a legal, medical, or any other professional.